đź“‹ FDA Reference
Acufex Suture Retriever Sterile Disposable
Acufex Microsurgical
Summary: The Acufex Suture Retriever is a sterile, disposable device used primarily in surgical procedures to retrieve sutures. It is commonly used by orthopedic surgeons and other specialists in minimally invasive surgeries.
FDA Clearance Information
Pathway ?
510(k)
Number ?
K881224 ↗
Decision Date ?
June 1, 1988
Product Code ?
GAE
Device Class ?
Class 1
Evidence ?
0 studies
The Acufex Suture Retriever was cleared through the FDA 510(k) pathway on June 1, 1988. It is manufactured by Acufex Microsurgical and classified as a Class 1 device under product code GAE.
What It Is
The Acufex Suture Retriever is a surgical instrument designed for the retrieval of sutures during procedures. It is sterile and disposable, ensuring a high standard of hygiene and reducing the risk of cross-contamination. The device is ergonomically designed to facilitate easy handling and precise control during surgery, making it an essential tool in minimally invasive procedures.
FDA-Cleared Indications
- Use during surgical procedures in which sutures must be retrieved or manipulated.
- Use for suture retrieval during minimally invasive soft-tissue repair procedures.
Clinical Applications
- Retrieving sutures during arthroscopic joint surgery.
- Retrieving sutures during arthroscopic shoulder or knee soft-tissue repair.
- Manipulating sutures during minimally invasive surgical repair when the device is appropriate for the procedure.
- Use in hospital or ambulatory surgical settings according to the product labeling and surgical technique.
Practical Considerations
- The device is sterile and disposable; it should not be reprocessed or reused unless the current manufacturer labeling specifically permits it.
- Available size and configuration options should be matched to the operative approach, access sheath or portal, tissue location, and suture size.
- Confirm compatibility with the suture material and other instruments before use; follow the device instructions and the surgeon's established technique.
- The record describes a mechanical surgical instrument and does not establish MRI safety. Do not bring it into the MRI environment unless current labeling confirms its MR status.
- Inspect the package and device before use. Do not use if the package is damaged, opened, expired, or if the instrument is bent or defective.
Frequently Asked Questions
What is the Acufex Suture Retriever used for?
It is used to retrieve sutures during surgical procedures, particularly in minimally invasive surgeries.
What specialties typically use this device?
Orthopedic surgeons, gynecologists, and general surgeons commonly use this device in minimally invasive procedures.
What are the FDA-cleared indications?
The device is indicated for use in surgeries requiring suture retrieval, especially in arthroscopic and minimally invasive procedures.
Disclaimer: This page compiles publicly available regulatory and published clinical evidence for educational reference.
It does not constitute medical advice, product endorsement, or a recommendation for clinical use.
Always consult manufacturer documentation and clinical judgment for patient care decisions.